Artificial Intelligence Graphic

Demystifying Regulatory Hurdles: How to Navigate FDA Approval for AI-Enabled Medical Devices

By Cory Hayes, Jeanna Blitz

…1/16/2024, https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices US Food and Drug Administration (FDA). Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD). Accessed 12/21/2023, https://www.fda.gov/media/122535/download?attachment US Food and…

…1/16/2024, https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices US Food and Drug Administration (FDA). Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD). Accessed 12/21/2023, https://www.fda.gov/media/122535/download?attachment US Food and…

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Erez Kaminski, Keryx

UL Certification: A Launchpad for Product Development Excellence

By Erez Kaminski

…let’s talk about why I hesitated and some key learnings for companies in the same position. Certifications Are Achievable for Small Companies There’s a common misconception that certifications are only…

…let’s talk about why I hesitated and some key learnings for companies in the same position. Certifications Are Achievable for Small Companies There’s a common misconception that certifications are only…

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AHRQ LOGO

AHRQ Issues Guide To Help Digital Health Developers and Users Advance Equity

…the digital capacity and infrastructure needs of the community and to understand the ways cultural beliefs in the community might impact the uptake of a solution. Real World Example: Find…

…the digital capacity and infrastructure needs of the community and to understand the ways cultural beliefs in the community might impact the uptake of a solution. Real World Example: Find…

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Dr. Ashkan Eliasy

A Framework for Navigating Information Polarization in MedTech Investment

By Dr. Ashkan Eliasy

…and ethical considerations continue to affect widespread acceptance of new technologies. Technological intervention in healthcare is praised as advancement in some societies and scrutinized in others. The most common cultural…

…and ethical considerations continue to affect widespread acceptance of new technologies. Technological intervention in healthcare is praised as advancement in some societies and scrutinized in others. The most common cultural…

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Person in lab

CDRH Releases New Dataset for Biocompatibility of Medical Devices

By MedTech Intelligence Staff

…devices in use. For more information, visit Biocompatibility and Toxicology Program: Research on Medical Devices, Biocompatibility, and Toxicology and Materials and Chemical Characterization Program: Research on the Materials and Chemical…

…devices in use. For more information, visit Biocompatibility and Toxicology Program: Research on Medical Devices, Biocompatibility, and Toxicology and Materials and Chemical Characterization Program: Research on the Materials and Chemical…

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Flex Recognized as a 2024 World’s Most Ethical Company

By MedTech Intelligence Staff

Contract manufacturer Flex has been recognized as one of Ethisphere’s 2024 World’s Most Ethical Companies in the category of industrial manufacturing. The award from Ethisphere requires companies to provide information…

Contract manufacturer Flex has been recognized as one of Ethisphere’s 2024 World’s Most Ethical Companies in the category of industrial manufacturing. The award from Ethisphere requires companies to provide information…

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FDA Logo

FDA Medical Device Sterilization Town Hall Series Continues April 29

By MedTech Intelligence Staff

As part of its efforts to work with the medical device community on device sterilization alternatives in light of new EPA standards for ethylene oxide (EtO) emissions, the FDA is…

As part of its efforts to work with the medical device community on device sterilization alternatives in light of new EPA standards for ethylene oxide (EtO) emissions, the FDA is…

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